ISO13485:2003, ISO14971:2000, CMDCAS, MDD 93/42/EEC - A risky business?
 

1. What is it about?
Compliance with the Medical Devices Directive is mandatory for organizations supplying devices to the European market. ISO 13485:2003 is the best benchmark for quality and regulatory compliance. After July 2006 your certification to the current standard will expire. The new standard offers significant additional benefits to management, quality assurance and production. It is accepted as best practice by the 148 member countries of ISO representing all the world’s major trading blocks including Europe, USA, Japan, Canada and Australia

As for the ISO 14791 is a replacement standard for EN1441. Although there are many similarities between the two standards, ISO14971 also asks manufacturers to meet some extra requirements in building a complete process on risk management at all stages of the products lifecycles.

Manufacturers selling class II, III and IV devices in Canada must be registered by a quality systems registrar accredited under the Canadian Medical Devices Conformity Assessment System(CMDCAS) by 1 January 2003. The deadline for the new version ISO 13485:2003 under CMDCAS will be 2006-03-15.

2. Why do you need it?
Medical devices are one of the most highly regulated groups of products manufactured in the world. In all instances and countries with major markets, a complex series of regulatory requirements must be met prior to launching a device into the market.

Regulatory requirements are in place to assure the efficacy, safety and integrity of soon-to-be-marketed devices. However, these same regulations can also cause major headaches for companies struggling with the intricacies of meeting a myriad of requirements while trying to introduce a new device to multiple markets.

Risk management forms an essential part of technical documentation under the Medical Device Directive and In Vitro Diagnostic Device Directive. Manufacturers need to be able to demonstrate that they have carried out a satisfactory risk analysis in order to meet the requirements of these directives and gain a CE mark.

3. How will the course benefit you?

During this three-day seminar you will learn methods and strategies enabling you to use this harmonised standard to meet the essential requirements of these directives or regulatory requirement. You will gain a practical understanding of what risk management means, requirement of regulatory, compliances to standards and how to apply it to your business.

4. Who Should Take this course?

• The Quality Management Representative of the company.
• Persons interested in gaining information and auditing skills critical to the new revision
• Any person that is about to lead the effort for system implementation at the company
• New members of the Management Representative Staff .
• Persons interested in auditing as a professional
• Those individuals that have inherited the reins for the QMS program at the company.

5. Course tutors: Mr. Marko Braeuning

 An experienced engineer in Medical Devices industry, who has worked for more than 8 years in the clinical and pre clinical area.

Beside being a Lead Tutor on Medical Devices standard and regulatory requirement, he is also competent to deliver audit activities for the standards ISO 9001:2000, ISO 13485:2003 , CMDCAS, Medical Device Directive 93/42 EEC and one of worldwide 45 external 3 rd party FDA accredited Inspectors outside USA.

He is the representative of the certification board of DQS for medical devices standards and a permanent member of CMDCAS Registrar meeting which held two times a year in Ottawa, Canada.

For detail kindly send your request to : info@dqs.com.my